Drug Catalog - Product Detail
IPRATROPIUM BROMIDE INHAL SOL. SOL 0.0002 25X2.5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-3798-83 | ACTAVIS PHARMA | 2 | 0.02% | SOLUTION |
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Description
DESCRIPTION The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, ( + )-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C 20 H 30 BrNO 3 •H 2 O Mol.Wt. 430.4 Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid. Chemical Structure for Ipratropium Bromide Monohydrate
How Supplied
HOW SUPPLIED Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. NDC 0591-3798-83, 25 vials in a foil pouch NDC 0591-3798-30, 30 vials in a foil pouch NDC 0591-3798-60, 60 vials, two foil pouches of 30 each Each vial is made from a low density polyethylene (LDPE) resin. Vials are supplied in a foil pouch. Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch. ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from Package Insert and dispense with solution. Rx Only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Manufactured by: The Ritedose Corporation Columbia, SC 29203 APRIL 2017
Indications & Usage
INDICATIONS AND USAGE Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Dosage and Administration
DOSAGE AND ADMINISTRATION The usual dosage of ipratropium bromide inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Ipratropium bromide inhalation solution unit-dose vials contain 500 mcg ipratropium bromide, USP anhydrous in 2.5 mL normal saline. Ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established.